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289 stories matching this filter · ← front page

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  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 17h agoNeutral↗ source
  • American Cancer Society updates prostate cancer screening guidance
    For the first time in 16 years, the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before it spreads.
    Fierce Biotech · 12h ago↗ source
  • Kyverna pauses development of next-gen autoimmune CAR-T KYV-102 to focus on neurologic miv-cel program
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Ophthalmology1079
Endocrinology & Metabolism785
Pain784
Nephrology764
Kyverna Therapeutics announced it is halting work on its next-generation CD19 CAR-T candidate KYV-102, which had been positioned as a follow-up to its lead autoimmune CAR-T miv-cel. KYV-102 was de…
Fierce Biotech · 1d agoNegative↗ source
  • Emory researchers identify 10-protein blood panel that detects ALS with 98% accuracy
    Researchers at Emory University have reported a new blood test that could spot amyotrophic lateral sclerosis much earlier than current methods. By measuring a set of ten proteins in plasma, the tes…
    Fierce Biotech · 2d agoPositive↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • FDA issues early alert as Arrow International recalls guidewires with spring wire guide components
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk issue with certain Arrow International guidewire products that contain spring wire guide c…
    fda medwatch · 3d agoRegulatoryNeutral↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 3d agoApprovalPositive↗ source
  • FDA orders label warnings for GLP-1 drugs over rare eye-loss risk
    The U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…
    fda medwatch · 4d agoRegulatoryNegative↗ source
  • Cardinal Health updates use instructions for Presource kits with BD Alaris infusion sets
    Cardinal Health has sent a letter to customers updating the use instructions for its Presource convenience kits that contain BD Alaris pump infusion sets. The update does not call for removal of t…
    fda medwatch · 4d agoCRLNeutral↗ source
  • Marea Therapeutics reports promising Phase 2b results for MAR001 in hypertriglyceridemia
    Marea Therapeutics, which recently merged with oncology firm Lisata Therapeutics, disclosed data from the first part of its phase 2b trial of the drug candidate MAR001. The study enrolled patients…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Rezera targets $181 million IPO to fund phase-3 trial of NLRP3 inhibitor for peripheral artery disease
    Boston-based biotech Rezera, which rebranded from NodThera last September, said it will seek an initial public offering to raise about $181 million. The proceeds are intended to move its brain-pene…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Agios to cut over 202 R&D positions as it awaits FDA decision on sickle cell drug
    Agios Pharmaceuticals said it will eliminate more than 100 research and development positions by the end of 2026, cutting its R&D workforce by roughly 35% from 2025 levels. The company entered the…
    Fierce Biotech · 8d agoLayoffsNegative↗ source
  • Blackstone Life Sciences and Boston Scientific launch $455 million partnership to develop next-generation heart pump
    Blackstone Life Sciences has entered a collaboration with Boston Scientific, committing $455 million to co‑fund development of a next‑generation miniature heart pump system. The device, called the…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Novartis ends $800M neuroscience partnership with BioArctic after 14 months
    Novartis signed an $800 million neuroscience partnership with BioArctic in August 2025, providing $30 million upfront to merge BioArctic’s BrainTransporter technology with a Novartis antibody targe…
    Fierce Biotech · 10d agoDealNegative↗ source
  • Abbott reports 30‑day success in Tectonic trial of SonicForce coronary IVL system
    Abbott announced that its investigational SonicForce Coronary IVL system achieved positive 30‑day outcomes in the Tectonic trial involving patients with severely calcified coronary artery disease.…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 11d agoDealNegative↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 11d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 13d agoApprovalPositive↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 14d agoCRLNegative↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 14d agoNegative↗ source
  • Ascletis oral GLP-1 candidate ASC30 meets primary and secondary goals in phase 2 diabetes study
    Ascletis reported that its oral GLP-1 small‑molecule candidate ASC30 achieved both its primary and secondary endpoints in a phase 2 trial involving 100 patients with type 2 diabetes. The study sho…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 16d agoNegative readoutNegative↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 16d agoPositive↗ source
  • Flagship launches Etcelera, an AI-driven biotech combining three platforms to predict drug effects
    Flagship Pioneering announced the formation of Etcelera, a new biotech emerging from stealth that will focus on AI-powered drug discovery. The company brings together the technologies of Cellarity…
    Fierce Biotech · 15d agoPositive↗ source